By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study. The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added. In the study, Lilly’s drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo. However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab’s results were “numerically higher” than its J&J counterpart, Lilly said. Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application ...
By Matt Olszewski Pictured: Eli Lilly headquarters in Indianapolis/iStock, jetcityimage Eli Lilly on Tuesday announced it has taken legal action against U.S. medical spas, wellness centers and compounding pharmacies for selling products with tirzepatide, the active ingredient in its blockbuster drug Mounjaro. Approved by the FDA to treat type 2 diabetes, Mounjaro is commercially available only through Lilly. The medication is also only available in prefilled single-dose pens. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro (tirzepatide) by medical spas, wellness centers and compounding pharmacies,” the company said in a statement In four different lawsuits filed in Florida and Texas federal courts, Lilly is seeking to ban Better Life Pharmacy, ReviveRX, ...
The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. The states argue Lilly is trying to use the deal to ward off future lawsuits by U.S. states. In a Tuesday filing in New Jersey federal court, lawyers for Arizona, Mississippi and Minnesota urged U.S. District Judge Brian Martinotti to delay approval of the deal unless it’s altered to make sure states can still file their own lawsuits over insulin prices. The states joined Illinois, Nebraska, Utah, Arkansas, Kansas and Montana in making their objections known this week. In a separate filing Monday, the group of six states argued that in light of local insulin price caps, Lilly was trying to settle claims valued at about $1 billion by offering price reductions that are already ...
By Tristan Manalac Pictured: Nektar signage at its headquarters in California/iStock, Sundry Photography Nektar Therapeutics on Monday revealed that former partner Eli Lilly had incorrectly calculated efficacy data for its investigational regulatory T-cell stimulator rezpegaldesleukin (rezpeg), which the company is developing as a treatment for atopic dermatitis. At the 31st Congress of the European Academy of Dermatology and Venereology (EADV), held in September 2022, Lilly presented data from a Phase Ib study of rezpeg, showing that while the candidate elicited positive and dose-dependent improvements in key efficacy measures, these effects ultimately fell short of statistical significance. At 12 weeks, Lilly erroneously reported the 12-µg/kg and 24-µg/kg doses of rezpeg were associated with a 53% and 66% improvement in Eczema Area and Severity Index (EASI) scores, respectively, whereas placebo induced a 49% improvement relative to baseline, Nektar reported. Neither dose was significantly superior to placebo, according to the company. However, Nektar’s ...
Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
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